Amarin Corporation PLC (AMRN) 2023 Q4 法說會逐字稿

Welcome to Amarin Corporation's conference call to discuss its fourth quarter in full year 2023 financial results and business updates. I would now like to turn the conference call over to Mark Marmur, Vice President Corporate Communications at Amarin.

歡迎參加 Amarin Corporation 的電話會議，討論 2023 年全年第四季的財務表現和業務更新。我現在想將電話會議轉給 Amarin 企業傳播副總裁 Mark Marmur。

Good morning, everyone, and thank you for joining us.

大家早安，感謝您加入我們。

Turning to our forward-looking statements. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided under federal securities law. We may not achieve our goals, carry on our plans or intentions or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change.

轉向我們的前瞻性陳述。請注意，本次電話會議將包含前瞻性聲明，這些聲明旨在涵蓋聯邦證券法規定的安全港。我們可能無法實現我們的目標、執行我們的計劃或意圖或滿足我們前瞻性聲明中所揭露的期望。實際結果或事件可能存在重大差異，因此您不應過度依賴這些陳述。我們不承擔隨著情況變化而更新這些聲明的義務。

Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that we may enter into, amend, or terminate. For additional information concerning the risk factors that could cause actual results to differ materially, please see the Risk Factors section of our annual report on Form 10-K for the year ended December 31, 2023, which has been filed with the SEC, and is available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents.

我們的前瞻性聲明並不反映我們可能簽訂的重大交易的潛在影響，例如合併、收購、處置、合資或任何我們可能簽訂、修改或終止的重大協議。有關可能導致實際結果出現重大差異的風險因素的更多信息，請參閱我們截至 2023 年 12 月 31 日的年度報告 10-K 表格中的風險因素部分，該報告已向 SEC 提交，並在可通過我們網站www.amarincorp.com 的投資者關係部分取得。我們鼓勵每個人閱讀這些文件。

An archive of this call will be posted on Amarin's website in the Investor Relations section.

本次電話會議的存檔將發佈在 Amarin 網站的投資者關係部分。

Turning to today's agenda. Patrick Holt, Amarin's President and Chief Executive Officer, will provide a brief overview of 2023 highlights and 2024 priorities; and Tom Reilly, Amarin's Chief Financial Officer, will provide a review of our fourth-quarter and full year 2023 financial results. Following prepared remarks, we will open the call to your questions.

轉到今天的議程。Amarin 總裁兼執行長 Patrick Holt 將簡要概述 2023 年亮點和 2024 年優先事項； Amarin 財務長 Tom Reilly 將回顧我們第四季和 2023 年全年的財務表現。在準備好發言後，我們將開始電話詢問您的問題。

I will now turn the call over to Patrick Holt, President and Chief Executive Officer of Amarin. Pat?

我現在將把電話轉給 Amarin 總裁兼執行長 Patrick Holt。拍？

Thank you, Mark. Good morning, everyone, and thank you for joining us today. Before we review our 2023 highlights and our 2024 priorities, I want to take a moment to reflect on our strategy at Amarin. Everyday, our team is focused on driving operational momentum to maximize the patient uptake of VASCEPA/VAZKEPA. To enhance the value of Amarin and deliver shareholder value, we must drive operational momentum across our three key regions. In Europe, where we have a potential IP runway out to 2039, we are focusing efforts and investment to accelerate prescription growth and revenue as well as secure pricing and reimbursement in those key markets. In the US, we're maintaining and extending our IP market leadership. And in the Rest of the World, we're enabling our partners to get our product into the hands of as many patients as possible. We firmly believe this focus on operator momentum is the best path forward for Amarin and will more strongly position us or potential future options.

謝謝你，馬克。大家早安，感謝您今天加入我們。在我們回顧 2023 年亮點和 2024 年優先事項之前，我想花點時間思考我們在 Amarin 的策略。我們的團隊每天都致力於推動營運勢頭，以最大限度地提高患者對 VASCEPA/VAZKEPA 的使用率。為了提升 Amarin 的價值並創造股東價值，我們必須推動三個關鍵地區的營運動能。在歐洲，我們擁有到 2039 年的潛在智慧財產權跑道，我們正在集中精力和投資來加速這些關鍵市場的處方成長和收入，以及安全的定價和報銷。在美國，我們正在維持並擴大我們的知識產權市場領導地位。在世界其他地區，我們正在幫助我們的合作夥伴將我們的產品送到盡可能多的患者手中。我們堅信，對營運商動力的關注是 Amarin 的最佳前進道路，並將為我們或未來潛在的選擇提供更強有力的定位。

Turning to slide 6. While we believe this strategy is the best way to deliver shareholder value today, the only way to gain shareholder confidence is to deliver against it. We have made meaningful progress in 2023, and we have clear priorities in place for 2024.

轉到投影片 6。雖然我們相信這項策略是當今實現股東價值的最佳方式，但獲得股東信心的唯一方法就是兌現這項策略。我們在 2023 年取得了有意義的進展，並且為 2024 年制定了明確的優先事項。

For Europe, in 2023, with new leadership and a more focused strategy in place, our teams made launch progress and have advanced pricing and reimbursement goals. In Spain, our team is focusing on health care practitioners who are early adopters of cardiovascular products. We are continuing to deliver strong launch progress such that we now have approximately 2,500 patients on therapy. In the United Kingdom, we have a more focused strategy in place, including driving uptake in key accounts. Currently, we have at least 1,500 patients on therapy.

對於歐洲，到 2023 年，在新的領導層和更集中的策略到位的情況下，我們的團隊取得了發布進展，並製定了先進的定價和報銷目標。在西班牙，我們的團隊專注於心血管產品早期採用者的醫療保健從業者。我們將繼續取得強勁的上市進展，目前已有約 2,500 名患者正在接受治療。在英國，我們制定了更有針對性的策略，包括推動大客戶的使用。目前，我們至少有 1,500 名患者正在接受治療。

Turning to pricing and reimbursement. We've secured pricing reimbursement across nine countries in Europe. As I have shared previously, we have strengthened our focus to advance our opportunities in key EU5 markets. I'm pleased to share in Italy, we have now resubmitted our dossier and will advance this process with the authorities to potentially achieve market access for VASCEPA by the end of 2024.

轉向定價和報銷。我們已在歐洲九個國家/地區獲得定價補償。正如我之前所分享的，我們加強了重點，以擴大我們在歐盟五國主要市場的機會。我很高興在義大利分享，我們現在已經重新提交了我們的檔案，並將與當局一起推進這一進程，以期在 2024 年底之前實現 VASCEPA 的市場准入。

In France and Germany, we are sharpening our scientific arguments and have strategies and plans in place to advance submissions for VASCEPA in these markets. We do not expect these processes to conclude in 2024. We'll continue to communicate progress on France and Germany as additional steps are achieved.

在法國和德國，我們正在強化我們的科學論證，並製定策略和計劃來推進 VASCEPA 在這些市場的提交。我們預計這些進程不會在 2024 年結束。隨著其他步驟的落實，我們將繼續通報法國和德國的進展。

Importantly, we are also aiming to successfully conclude pricing reimbursement decision in at least five additional markets in 2024. We remain confident in our path forward in Europe. We have patents and applications that have the potential to extend our IP up to 2039. As a testament of this progress, we successfully defended our 2033 patent from opposition. We expect to share more on this topic in the coming months.

重要的是，我們還計劃在 2024 年至少在另外五個市場成功做出定價補償決策。我們對歐洲的前進道路仍然充滿信心。我們擁有的專利和應用程式有可能將我們的智慧財產權延長至 2039 年。作為這一進步的證明，我們成功捍衛了我們的 2033 專利免受異議。我們預計在未來幾個月內就該主題分享更多資訊。

Turning to the United States. In 2023, we continue to extend IP market leadership, closing the year with a 57% market share. We achieved this through focused investment in managed care, trade, and medical capabilities to extend VASCEPA's life cycle despite the elimination of our sales force and reduced marketing spend in July.

轉向美國。2023 年，我們將繼續擴大 IP 市場領先地位，以 57% 的市佔率結束這一年。儘管 7 月我們取消了銷售團隊並減少了行銷支出，但我們透過集中投資管理式醫療、貿易和醫療能力來延長 VASCEPA 的生命週期，從而實現了這一目標。

As we turn to 2024, we have begun the year in a slightly improved position compared to last year. Based on what we currently know with our exclusive accounts, these represent at least 50% of the total IP market volume. While we are encouraged to start the year in a solid managed care position, the market remains highly dynamic, and we continue to monitor this closely. We do expect Q1 2024 results to be impacted by typical first-quarter payer dynamics. We continue to stand ready to execute aggressive approaches, including the potential future launch of an authorized generic bolstered by our strong supply position to retain market leadership within the IP market.

展望 2024 年，我們的開年狀況比去年略有改善。根據我們目前對獨家帳戶的了解，這些帳戶至少佔 IP 市場總量的 50%。雖然我們被鼓勵以穩固的管理醫療地位開始新的一年，但市場仍然高度活躍，我們將繼續密切關注這一情況。我們確實預期 2024 年第一季的業績將受到典型的第一季付款人動態的影響。我們繼續準備採取積極的措施，包括未來可能推出授權仿製藥，並在我們強大的供應地位的支持下，以保持知識產權市場的市場領先地位。

In the Rest of World, in 2023, we made progress on regulatory market access and commercial fronts as well as new partnerships. In China, the second largest cardiovascular market globally, Amarin's partner, Edding, launched VASCEPA in October for the very high triglycerides indication. Additionally, that NMPA has accepted the regulatory filing for the cardiovascular risk reduction indication, which opens up the potential for future national reimbursement and drug listing.

2023 年，在世界其他地區，我們在監管市場准入和商業方面以及新的合作夥伴關係方面取得了進展。在全球第二大心血管市場中國，Amarin 的合作夥伴 Edding 於 10 月推出了 VASCEPA，用於治療極高三酸甘油酯的適應症。此外，國家藥監局已接受心血管風險降低適應症的監管備案，這為未來國家報銷和藥品上市開闢了可能性。

In 2023, Amarin also entered into three new partnerships across 15 countries. In 2024, our focus for Rest of World shifts toward enabling our partners to obtain market access and commercial uptake across key markets.

2023 年，Amarin 還在 15 個國家建立了三個新的合作關係。2024 年，我們在世界其他地區的重點將轉向幫助我們的合作夥伴獲得關鍵市場的市場准入和商業應用。

Finally, in Research and Development and Medical, our teams delivered important progress with data publications and medical education supporting our brand globally to build confidence in our science. In 2024, we will continue to build on this momentum, including additional data on REDUCE-IT and EPA. Indeed, we have seven abstracts at the upcoming American College of Cardiology meeting in April. We'll be showing more on this in coming weeks.

最後，在研發和醫療領域，我們的團隊透過數據出版和醫學教育取得了重要進展，在全球範圍內支持我們的品牌，建立了對我們科學的信心。2024 年，我們將繼續鞏固這一勢頭，包括有關 REDUCE-IT 和 EPA 的更多數據。事實上，我們在四月即將舉行的美國心臟病學會會議上有七份摘要。我們將在未來幾週內展示更多相關內容。

This important operational progress has supported our financial position, with $321 million in cash and no debt. As you're aware, due to our recent progress in our financial position, we announced plans for a share repurchase program of up to $50 million. I'm pleased to share that we are on track to complete the necessary shareholder and UK High Court approvals. We continue to anticipate completing these steps in the second quarter of 2024, and that share repurchases would commence shortly thereafter.

這項重要的營運進展支持了我們的財務狀況，我們擁有 3.21 億美元現金且無債務。如您所知，由於我們最近的財務狀況取得了進展，我們宣布了高達 5000 萬美元的股票回購計劃。我很高興地告訴大家，我們正在完成必要的股東和英國高等法院的批准。我們繼續預計這些步驟將在 2024 年第二季完成，股票回購將在不久後開始。

In summary, 2023 was a meaningful year for operational momentum, and we are well positioned to continue to build on this in 2024.

總之，2023 年是營運動能有意義的一年，我們已做好充分準備，在 2024 年繼續在此基礎上再接再厲。

Now, I'd like to hand over the call to Tom Reilly to review our fourth-quarter and year end 2023 financial performance. Tom?

現在，我想將電話轉交給 Tom Reilly，回顧我們第四季和 2023 年底的財務表現。湯姆？

Thank you, Pat. Good morning, everyone. I'm pleased to report details on our financial performance for the fourth quarter of 2023.

謝謝你，帕特。大家，早安。我很高興報告 2023 年第四季財務業績的詳細資訊。

In the fourth quarter of 2023, Amarin reported total net revenue of $74.7 million, including net product revenue of $70.6 million versus $66.1 million in the third quarter of 2023 and $4.2 million in licensing and royalty revenue.

2023 年第四季度，Amarin 報告的總淨收入為 7,470 萬美元，其中產品淨收入為 7,060 萬美元，而 2023 年第三季為 6,610 萬美元，許可和特許權使用費收入為 420 萬美元。

US product revenue was $64.9 million, with stable performance in the US despite multiple competing generics on the market. The US business continues to provide profit supporting our expansion into Europe.

美國產品收入為 6,490 萬美元，儘管市場上存在多種競爭性仿製藥，但其在美國的表現穩定。美國業務繼續提供利潤支持我們向歐洲擴張。

The revenue results include Europe [PM] product revenue of $1.5 million, a 65% increase versus the third quarter of 2023, reflecting early revenues from European markets, including Spain and the United Kingdom. We recognized $8.4 million in the Rest of World revenue in the fourth quarter of 2023, including product revenue of $4.2 million related to commercial sales to our partners in Canada, China and the Middle East, and licensing and royalty revenue of $4.2 million, resulting primarily from the achievement of the Edding CVRR milestones.

收入結果包括歐洲 [PM] 產品收入 150 萬美元，較 2023 年第三季增長 65%，反映了來自歐洲市場（包括西班牙和英國）的早期收入。2023 年第四季度，我們在世界其他地區確認了840 萬美元的收入，其中包括與加拿大、中國和中東合作夥伴商業銷售相關的420 萬美元產品收入，以及420 萬美元的許可和特許權使用費收入，這主要是由於來自 Edding CVRR 里程碑的實現。

Cost of goods sold in the fourth quarter of 2023 were $29.6 million compared to $23.6 million, excluding restructuring in the third quarter in 2023. Amarin's overall gross margin on net product revenue in the fourth quarter was 58% compared with 64% in the third quarter of 2023. This was primarily due to an increase in one supply sales to our partner, Edding.

2023 年第四季的銷售成本為 2,960 萬美元，而不包括 2023 年第三季的重組成本為 2,360 萬美元。Amarin 第四季淨產品收入的整體毛利率為 58%，而 2023 年第三季為 64%。這主要是由於我們的合作夥伴 Edding 的一項供應銷售增加。

Moving on to operating expenses. Operating expenses were $49.7 million in the fourth quarter, comprised of $43.9 million in selling and general and administrative expenses, and $5.8 million in research and development expenses. In the second half of 2023, Amarin reported operating expenses of $101.2 million. This represents a $21 million reduction in operating expenses versus the first half of 2023.

接下來是營運費用。第四季營運費用為 4,970 萬美元，其中包括 4,390 萬美元的銷售、一般及管理費用以及 580 萬美元的研發費用。2023 年下半年，Amarin 報告營運費用為 1.012 億美元。這意味著與 2023 年上半年相比，營運費用減少了 2,100 萬美元。

We are on track to deliver the previously announced $40 million reduction in operating expenses by July 2024. Amarin reported a net loss of $5.8 million for the fourth quarter of 2023 or basic and diluted loss per share of $0.01.

我們預計在 2024 年 7 月之前實現之前宣布的 4,000 萬美元營運費用削減。Amarin 公佈 2023 年第四季淨虧損 580 萬美元，每股基本虧損和攤薄虧損為 0.01 美元。

Let me now turn to our efforts and results in controlling costs and effectively managing our cash. As of December 31, 2023, Amarin reported aggregate cash and investments of $321 million. Importantly, this is the sixth consecutive quarter of positive or neutral cash flow generation for Amarin, and our cash balance is now $10 million higher when compared to December 31, 2022.

現在讓我談談我們在控製成本和有效管理現金方面的努力和成果。截至 2023 年 12 月 31 日，Amarin 報告的現金和投資總額為 3.21 億美元。重要的是，這是 Amarin 連續第六個季度產生正現金流或中性現金流，與 2022 年 12 月 31 日相比，我們的現金餘額目前增加了 1000 萬美元。

In 2023, we made progress in controlling our costs and managing our cash position through our cost reduction programs and renegotiating supply agreements. In 2024, we will continue to focus on cash preservation prudently invest in right opportunities, particularly in Europe, based on pricing reimbursement decisions and pending shareholder and UK High Court approvals will initiate our shareholder repurchase program.

2023 年，我們透過成本削減計劃和重新談判供應協議，在控製成本和管理現金狀況方面取得了進展。2024年，我們將繼續專注於現金保存，根據定價償還決定和待決的股東和英國高等法院的批准，謹慎投資於正確的機會，特別是在歐洲，並將啟動我們的股東回購計劃。

With that, I will now turn the call back over to Pat for closing remarks and to begin the Q&A portion of our call. Pat?

現在，我將把電話轉回給帕特進行結束語，並開始電話的問答部分。拍？

Thank you, Tom, for the financial overview of our results. Our team is focused on operational momentum to maximize shareholder value across all three areas of our business. We believe we have the right plan, focus on operational momentum to drive shareholder value. We have a strong future because of our fundamentals, best-in-class science supporting VASCEPA/VAZKEPA, a large global opportunity to impact cardiovascular patients, a team that is dedicated to delivering results, and a strong balance sheet.

湯姆，謝謝您對我們業績的財務概述。我們的團隊專注於營運動力，以最大限度地提高我們所有三個業務領域的股東價值。我們相信我們有正確的計劃，專注於營運動力以推動股東價值。我們擁有美好的未來，因為我們的基本面、支持 VASCEPA/VAZKEPA 的一流科學、影響心血管患者的巨大全球機會、致力於交付成果的團隊以及強大的資產負債表。

Finally, thank you to our colleagues for their commitment and dedication. I look forward to driving shareholder value together.

最後，感謝我們的同事的承諾和奉獻。我期待共同推動股東價值。

And with that, Mark, let's begin the Q&A portion of the call.

馬克，接下來讓我們開始電話的問答部分。

Thank you, Pat. As we announced last year to enhance engagement with the company's shareholder base and facilitate connections with its investors, Amarin is partnering with Say Technologies to allow retail and institutional shareholders to submit and upvote questions, a selection of which will be answered by Amarin management during today's earnings call.

謝謝你，帕特。正如我們去年宣布的那樣，為了加強與公司股東基礎的接觸並促進與投資者的聯繫，Amarin 正在與Say Technologies 合作，允許散戶和機構股東提交和投票問題，Amarin 管理層將在今天的會議上回答其中的一些問題財報電話會議。

Let's begin the Q&A. So, Pat, we've received a number of questions on the company's long-term strategy and ways that we plan to maximize shareholder value. What would you say to these investors?

讓我們開始問答。帕特，我們收到了一些有關公司長期策略以及我們計劃實現股東價值最大化的方式的問題。您想對這些投資者說什麼？

Thanks for the question. I get this question a lot. It's a really important question, and we believe the best path forward for us to both increase our value and put us in the best possible place for future strategic options is, today, to focus on our current efforts around operational momentum, whether that be in Europe, in the US, or in the rest of the world. As we shared earlier in the call, we really are making progress on all three fronts, which provides us greater optimism and optionality for the future.

謝謝你的提問。我常被問到這個問題。這是一個非常重要的問題，我們相信，對我們來說，既要增加價值，又要讓我們在未來戰略選擇中處於最佳位置，最好的前進道路是，今天，專注於我們當前圍繞運營勢頭所做的努力，無論是在歐洲、美國或世界其他地區。正如我們早些時候在電話會議中分享的那樣，我們確實在所有三個方面都取得了進展，這使我們對未來更加樂觀和有更多選擇。

Great. Thanks, Pat. Our second set of questions focuses on China and Asia Pacific. What can you tell us on progress around the commercial launch in China, and what is the status of the cardiovascular risk reduction regulatory following China? Also, more broadly in Asia Pacific, can you share any updates on efforts with our partners?

偉大的。謝謝，帕特。我們的第二組問題集中在中國和亞太地區。您能告訴我們有關在中國商業上市的進展嗎？中國降低心血管風險的監管狀況如何？此外，在更廣泛的亞太地區，您能否與我們的合作夥伴分享最新的努力？

Well, there's a lot in that. And as some of you know, I know this region pretty well. So let me break that down in some parts.

嗯，其中有很多內容。正如你們中的一些人所知，我非常了解這個地區。讓我把它分成幾個部分。

Firstly, to the China launch. So Amarin's partner, Edding, is really making important progress in China, which I'll remind everybody, is the second-largest cardiovascular market globally. Edding have launched VASCEPA for very high triglycerides in Q4 2023. To give you a flavor, the Edding sales force is covering 200 hospitals, which includes around 500 key opinion leaders, the majority of which are cardiologists in the three largest cities of Beijing, Shanghai and Guangzhou. So in summary, the launch is progressing well, and the structure of the agreement provides immediate profitability to Amarin.

首先是在中國的推出。因此，Amarin 的合作夥伴 Edding 在中國確實取得了重要進展，我要提醒大家的是，中國是全球第二大心血管市場。Edding 於 2023 年第四季推出了針對極高三酸甘油酯的 VASCEPA。跟大家介紹一下，愛丁的銷售隊伍涵蓋了200家醫院，其中包括約500名關鍵意見領袖，其中大多數是北京、上海、廣州三大城市的心臟科醫生。總而言之，此次發布進展順利，協議結構為 Amarin 提供了即時的獲利能力。

So let's move from today and also think about the future in China as we reflect upon the cardiovascular risk reduction indication. The NMPA has accepted the regulatory filing for cardiovascular risk reduction, which opens up the potential for national reimbursement drug listing. The submission was accepted with a clinical trial waiver, meaning a separate clinical trial will not be required in order to be reviewed for approval. The teams are now focused on advancing that submission together with the authorities, and we expect the regulatory review process to conclude in 2025.

因此，讓我們從今天開始，在反思心血管風險降低指標時，思考中國的未來。NMPA已接受降低心血管風險的監管備案，這為國家報銷藥品上市開闢了可能性。該提交被接受並獲得臨床試驗豁免，這意味著不需要進行單獨的臨床試驗即可獲得審查批准。這些團隊現在專注於與當局一起推進提交申請，我們預計監管審查流程將於 2025 年結束。

Asia Pacific is a large region, so let me just touch on some other areas within the region. As you know, last year, we entered into partnerships in Australia and New Zealand, with CSL Seqirus, and also 11 Asian markets, including South Korea with Lotus Pharmaceuticals. I'm pleased to share that CSL is advancing pricing and reimbursement processes in Australia with the authorities. And in other markets, our partner, Lotus, is advancing regulatory discussions and filings with the various authorities across the region.

亞太地區是一個很大的地區，所以讓我談談該地區的其他一些領域。如您所知，去年我們在澳洲和紐西蘭與 CSL Seqirus 建立了合作夥伴關係，並在韓國等 11 個亞洲市場與 Lotus Pharmaceuticals 建立了合作夥伴關係。我很高興地告訴大家，CSL 正在與當局一起推動澳洲的定價和報銷流程。在其他市場，我們的合作夥伴蓮花正在與該地區的各個當局推進監管討論和備案。

Great. Thanks, Pat, for that information on China and Asia Pacific. Now turning to the US. Is there a path toward growth in the market? Could we potentially take market share from other products or classes?

偉大的。謝謝帕特提供有關中國和亞太地區的資訊。現在轉向美國。市場有成長的途徑嗎？我們是否有可能從其他產品或類別中奪取市場份額？

Great question. And naturally, our US revenues and cash flows are incredibly important to our business. When we take a step back and we think about the US market and where it stands today, it's important to remember that the IP market in the US is highly genericized at this point.

很好的問題。當然，我們在美國的收入和現金流對我們的業務非常重要。當我們退一步思考美國市場及其今天的狀況時，重要的是要記住，美國的智慧財產權市場目前是高度通用的。

Our focus has been and continues to be to maintain IP market leadership. And as a result of that, not focused on growing the market. We really have achieved a highly atypical performance three years post LOA to end 2023 with a market-leading share of 57%. We've been able to secure market leadership and continue our success through our exclusive contracts, led by our capabilities in payer, managed care, and medical areas.

我們的重點一直是並將繼續是保持知識產權市場的領先地位。因此，沒有專注於發展市場。LOA 後三年到 2023 年底，我們確實取得了非常非典型的業績，市佔率為 57%。在付款人、管理式醫療和醫療領域的能力的引領下，我們能夠透過獨家合約確保市場領導地位並繼續取得成功。

Again, as we mentioned, we've started 2024 in a strong position in terms of our exclusive contracts. But to remind everybody, the dynamic market, and we do watch it very closely and continue to assess our optionality for our branded product and beyond that should we consider other strategic alternatives.

正如我們所提到的，我們在 2024 年伊始就在獨家合約方面處於有利地位。但要提醒大家的是，市場充滿活力，我們確實非常密切地關注它，並繼續評估我們品牌產品的可選性，除此之外我們是否應該考慮其他策略替代方案。

In terms of taking share from other products or classes, given those generic dynamics, we do not view this as an optimal strategy.

就從其他產品或類別中獲取份額而言，考慮到這些一般動態，我們並不認為這是最佳策略。

Thank you. Turning to supply. If we see demand increase from Europe or Rest of World partners, are you confident that we can meet those supply demands?

謝謝。轉向供應。如果我們看到歐洲或世界其他合作夥伴的需求增加，您是否有信心我們能夠滿足這些供應需求？

It's a very important question. And we do have strong relationships with our key supply partners. Over the last several years, we've made really important progress, renegotiating our supply agreements to ensure that we can both meet our demands as well as reduce key supply commitments. We feel really confident that we can meet those supply demands moving forward.

這是一個非常重要的問題。我們確實與主要供應合作夥伴建立了牢固的關係。在過去的幾年裡，我們取得了非常重要的進展，重新談判了我們的供應協議，以確保我們既能滿足我們的需求，又能減少關鍵的供應承諾。我們非常有信心能夠滿足未來的供應需求。

Now, one last question on the R&D side from the Say Technologies questions. Is Amarin working on advancing any additional indications for VASCEPA/VAZKEPA?

現在，Say Technologies 的問題涉及研發方面的最後一個問題。Amarin 是否正在致力於推進 VASCEPA/VAZKEPA 的任何其他適應症？

I was really pleased this question came up. And it's such an important question when you think about the core strength that Amarin has in terms of our R&D team and our IP capabilities and leadership. This is the team that has developed and advance the molecule from day one, and deliver the REDUCE-IT data that really has a global impact that we see today. With our team in place, we do continue to look at opportunities for new indications and we will update investors based on potential future progress of that work.

我真的很高興這個問題的出現​​。當您考慮 Amarin 在研發團隊、智慧財產權能力和領導力方面的核心優勢時，這是一個非常重要的問題。這個團隊從第一天起就開發和推進了該分子，並提供了真正具有我們今天看到的全球影響力的 REDUCE-IT 數據。隨著我們的團隊就位，我們將繼續尋找新適應症的機會，並將根據這項工作未來的潛在進展向投資者通報最新情況。

So before we take additional questions, I'd like to thank those shareholders who submitted questions via the Say Technologies platform. We are committed to continuing open and transparent dialogue with all of our shareholders, and the Say Technologies platform is one way that we are trying to increase engagement and two-way dialogue with you. We look forward to continuing to hear from you and answering your questions on this platform as well as other opportunities moving forward.

因此，在我們提出其他問題之前，我要感謝那些透過 Say Technologies 平台提交問題的股東。我們致力於繼續與所有股東進行公開、透明的對話，而 Say Technologies 平台是我們努力增加與您的參與和雙向對話的一種方式。我們期待繼續在這個平台上收到您的來信並回答您的問題以及未來的其他機會。

Thank you for those updates, Pat. We'll now open the Q&A up for additional questions.

謝謝你的更新，帕特。我們現在將針對其他問題開放問答。

(Operator Instructions) Roanna Ruiz, Leerink Partners.

（操作員說明）Roanna Ruiz，Leerink Partners。

So could you talk a bit more about the ongoing generic competition in the US? Like what trends are you seeing in the field? And what do you expect in terms of possible pressure on VASCEPA net price in the next couple of years?

那麼您能多談談美國正在進行的仿製藥競爭嗎？您在該領域看到了哪些趨勢？您對未來幾年 VASCEPA 淨價可能面臨的壓力有何預期？

Hi, Roanna. Good morning. Thanks so much for the question. Great to hear from you. As you probably have followed, there are more generics that have got regulatory approval, there are more generics that have also got prices. And with that said, what we see in terms of the market dynamics in the market so far, they remained fairly stable.

嗨，羅安娜。早安.非常感謝您的提問。很高興聽到你的消息。正如您可能已經註意到的那樣，有更多的仿製藥已獲得監管部門的批准，有更多的仿製藥也已定價。話雖如此，從迄今為止的市場動態來看，它們仍然相當穩定。

So as we mentioned, we closed the year and we started the year with a strong position with our exclusive contracts that represents greater than 50% of the IP volume. So as we end the year and start the year, we are feeling really good about that position. But as I'm sure you've noted, there is more dynamics and there are more entrants in the market. So we continue to monitor it very closely.

正如我們所提到的，我們在今年結束時以佔知識產權總量 50% 以上的獨家合約佔據了強勢地位。因此，當我們在年底和年初時，我們對這個職位感覺非常好。但我相信您已經注意到，市場上有更多的活力和更多的進入者。因此，我們將繼續密切監視它。

But I would say so far, and we haven't seen any dynamic changes from what we have seen historically. But obviously, we track it closely. And as you know, we have optionality in the short term as well as the long term to maximize the economics for us in the US.

但我想說的是，到目前為止，我們還沒有看到任何與歷史上所見的動態變化。但顯然，我們密切跟踪它。如您所知，我們在短期和長期都有選擇，可以最大限度地提高美國的經濟效益。

Yep, makes sense. And a quick follow-up on the Rest of World. I noticed it's gaining some traction. So could you talk about what regions you expect might contribute the most momentum to future growth in revenues in 2024 and beyond?

是的，有道理。以及對世界其他地區的快速跟進。我注意到它正在獲得一些關注。那麼您能否談談您預計哪些地區可能對 2024 年及以後的營收成長貢獻最大動力？

Yeah, it's a great question. As I mentioned, we're really -- it's pleasing to see the progress in 2023. As you think, we always -- we signed up some new countries in 2023. If you take a step back in 2023, the main revenue sources, until China came on board, was really coming from Canada and then parts of Middle East, North Africa. So what we'll see in 2024 is certainly continued value coming from those existing partnerships such as I've just mentioned. So I do expect that China will have more progress in 2024.

是的，這是一個很好的問題。正如我所提到的，我們真的很高興看到 2023 年的進展。正如您所想，我們一直在 2023 年簽署了一些新國家的協議。如果退一步看，2023 年，在中國加入之前，主要收入來源實際上來自加拿大，然後是中東和北非的部分地區。因此，我們在 2024 年將看到的肯定是來自我剛才提到的現有合作夥伴關係的持續價值。所以我確實預計中國在2024年會有更多進步。

And then there is the opportunity, I think as some of these partnerships start to go from signing through regulatory process such as Lotus, market access, reimbursement and pricing, such as CSL Seqirus in Australia, New Zealand, you're starting to see a shift from entering partnerships to really more driving through those pre-commercial and commercial outputs. So we're pleased that we're progressing through that life cycle of partnership and alliance management, I would say, and we see that shift in the business towards more revenue -- market access and revenue generation. And internally, that means we're beefing up our capabilities and leadership to support that growth.

然後還有機會，我認為，隨著其中一些合作夥伴關係開始從簽署到監管流程，例如 Lotus、市場准入、報銷和定價，例如澳大利亞、新西蘭的 CSL Seqirus，您將開始看到從建立合作夥伴關係轉向真正更多地推動這些預商業和商業產出。因此，我們很高興我們正在夥伴關係和聯盟管理的生命週期中取得進展，我想說，我們看到業務向更多收入的轉變——市場准入和創造收入。在內部，這意味著我們正在增強我們的能力和領導力來支持這種成長。

Got it. Thanks.

知道了。謝謝。

And that's -- to add that. It's really -- it is a key part of our goals and our strategy, that Rest of World business, and it provides immediate profitability for us.

補充一點。這確實是我們的目標和策略的關鍵部分，即世界其他地區的業務，它為我們提供了直接的獲利能力。

Jessica Fye, JPMorgan.

潔西卡法耶，摩根大通。

This is [Na Sun] on for Jessica Fye. I have a question on your progress in launching VASCEPA there. Can you just talk a little bit about how to accelerate the growth in UK? And then for Germany, have you come up with a plan to reenter the market there? And then for Italy as well. Thank you.

這是 Jessica Fye 的 [Na Sun]。我對你們在那裡推出 VASCEPA 的進展有疑問。能談談如何加速英國的成長嗎？那麼對於德國，你們有沒有製定重新進入那裡市場的計畫？然後是義大利。謝謝。

Thanks, Na Sun. Look, Europe is obviously critical for us. It's a key focus of our investments and a key focus of the whole organization as we move forward. So as we break that down, we think about those key launch markets. And as we've previously mentioned, the UK is quite an individual market, and the uptake in the UK is typically solo. We are making progress with a more focused strategy on those key accounts. And as I signaled earlier, we now believe -- we estimate we have at least 1,500 patients on therapy.

謝謝，孫娜。看，歐洲顯然對我們至關重要。這是我們投資的重點，也是整個組織前進的重點。因此，當我們進行細分時，我們會考慮那些關鍵的發布市場。正如我們之前提到的，英國是一個相當獨立的市場，英國的吸收通常是單獨的。我們正在透過針對這些關鍵客戶的更集中的策略來取得進展。正如我之前所暗示的，我們現在相信——我們估計至少有 1,500 名患者正在接受治療。

Building on that, we did say from that moment of launch last September that we did expect Spain to be a faster uptake market, and that is proving true. So we're pleased with the progress and the uptake we're seeing in Spain on a national basis. And today, we see -- we estimate we have around 22,600 patients on therapy, which is important progress for us.

在此基礎上，我們確實從去年 9 月推出的那一刻起就說過，我們確實預期西班牙將成為一個更快的吸收市場，事實證明這是真的。因此，我們對西班牙全國範圍內所取得的進展和採用率感到滿意。今天，我們估計大約有 22,600 名患者正在接受治療，這對我們來說是重要的進展。

So they're two key launch markets for us. As we move into some of the reimbursement markets, we've resubmitted in Italy, building on our previous strong scientific assessment, and we do expect Italy pricing reimbursement to conclude in 2024.

因此，它們是我們兩個主要的啟動市場。隨著我們進入一些報銷市場，我們基於先前強有力的科學評估，在義大利重新提交了申請，我們預計義大利的定價報銷將於 2024 年結束。

And then if we think about Germany, to your next question, you know our history in Germany. So that's a topic where we've taken a step back and we are redeveloping a potential new strategy to enter the market. We're working with the authority to assess different ways to consider patient populations that can be relevant for the German market, and we're working with the authorities on those plans, and we continue to advance that through 2024. But as I mentioned, I don't expect that those processes will conclude in 2024. Thanks very much for the question.

然後，如果我們想到德國，對於你的下一個問題，你知道我們在德國的歷史。因此，我們在這個主題上退了一步，正在重新制定進入市場的潛在新策略。我們正在與當局合作，評估考慮與德國市場相關的患者群體的不同方法，我們正在與當局合作制定這些計劃，我們將繼續推進到 2024 年。但正如我所提到的，我預計這些進程不會在 2024 年結束。非常感謝您的提問。

Louise Chen, Cantor Fitzgerald.

路易絲·陳，坎托·菲茨杰拉德。

This is Wayne on for Louise. So first, you have reiterated that you're on track to deliver the $40 million annual savings. And so how should we think about the operating expense for 2024? Because compared to the second quarter, you saved about $7 million in the third quarter and $8 million this quarter? So should we expect a similar number going forward? And then the gross margin has dropped to 58%. So how should we think about this going forward? Thank you.

這是韋恩為路易絲代言的。首先，您重申您有望實現每年 4000 萬美元的節省。那我們該如何考慮2024年的營運費用呢？因為與第二季相比，第三季您節省了大約 700 萬美元，本季節省了 800 萬美元？那麼我們是否應該預期未來會有類似的數字呢？然後毛利率下降到58%。那我們該如何看待這個問題呢？謝謝。

Yeah, great. Thank you. This is Tom. Thanks for the question.

很好。謝謝。這是湯姆。謝謝你的提問。

Related to the operating expense and the $40 million, which we're on track to deliver and what we are expecting -- our expectations for expenses. As mentioned before, we reduced expenses from the second half to the first half of '23 by $21 million. Our cost basis is approximately $50 million per quarter. Our expectation is to stay within that range, depending on pricing reimbursement decisions. We'll invest in those opportunities, but we'll find other ways to reduce costs. So our overall expectation is to stay within that $50 million operating expense basis.

與營運費用和 4000 萬美元相關，我們正在按計劃交付這些費用，以及我們的預期——我們對費用的預期。如前所述，我們從 2023 年下半年到上半年減少了 2,100 萬美元的支出。我們的成本基礎約為每季 5000 萬美元。我們的期望是保持在這個範圍內，這取決於定價報銷決策。我們將投資這些機會，但我們會找到其他方法來降低成本。因此，我們的整體預期是保持在 5000 萬美元的營運費用基礎上。

Related to your question on gross margin, very good question. Thanks for picking it up. What you've seen versus Q3 is a deterioration of gross margin, but that's primarily due to launch supply that we provided for our partners, in particular in China. So as the China market is moving forward, we're providing products for revenue there. It's about a 2.5- to 3-point reduction in margin impact this quarter versus the previous quarter.

與你關於毛利率的問題有關，非常好的問題。謝謝你把它撿起來。與第三季相比，您看到的是毛利率的惡化，但這主要是由於我們為合作夥伴提供的推出供應，特別是在中國。因此，隨著中國市場的發展，我們正在為那裡提供產品以獲取收入。本季對利潤率的影響與上一季相比大約減少了 2.5 到 3 個百分點。

And then the question on how do you expect for margins moving forward. I think it all depends on the uptake in China and how much product (inaudible) we'll be providing. But we'll give updates on the progress of the China market.

然後是關於您對未來利潤率的預期如何的問題。我認為這完全取決於中國的吸收情況以及我們將提供多少產品（聽不清楚）。但我們將提供有關中國市場進展的最新資訊。

Thank you very much.

非常感謝。

Paul Choi, Goldman Sachs.

保羅‧崔，高盛。

This is Khalil calling in for Paul. I guess my question is about the exclusive contracts that you've mentioned in the past. As those are renegotiated, have you seen any additional pushback as more generics enter the market? And have you or will you set a threshold for those sort of deterioration on those at which point the company would pivot to your own generic?

我是卡里勒來找保羅。我想我的問題是關於你過去提到的獨家合約。隨著這些重新談判，隨著更多仿製藥進入市場，您是否看到任何額外的阻力？您是否或將會為這些惡化設定一個閾值，屆時公司將轉向您自己的仿製藥？

Khalil, thanks very much for the question. Look, obviously, we track those contracts very carefully. We do see, I would say, on an annual basis, to renegotiate our exclusive contract, we do see annual impact to those pricings in the sort of low double-digit range typically. And that's been something that we are seeing consistently. We don't see necessarily significant changes to that, but that's the sort of range that we see.

卡里爾，非常感謝你的提問。顯然，我們非常仔細地追蹤這些合約。我想說，我們確實看到，每年重新談判我們的獨家合同，我們確實看到這些定價的年度影響通常在較低的兩位數範圍內。這是我們一直看到的事情。我們認為這不一定會發生重大變化，但這就是我們看到的範圍。

What's really pleasing is we have had a strong end to the year and a strong start to the year in terms of how we're landing our negotiations. So the net-net of that means that we are participating in greater than 50% of the IP market volume. That has enabled us with our great managed care and trade and medical capabilities to pull through as we close 2023, a 57% market share in retained market leadership.

真正令人高興的是，就我們如何進行談判而言，我們在今年有一個良好的結束和一個好的開始。因此，這意味著我們參與了超過 50% 的 IP 市場容量。這使我們能夠憑藉出色的管理式醫療以及貿易和醫療能力，在 2023 年結束時渡過難關，佔據 57% 的市場份額，保持市場領先地位。

To your second part of your question, of course, we track the economics and the overall profitability incredibly closely. We have specific scenarios in our mind as to when we think those are attractive and when they start to become more marginal, and we have plans in place to react based on how those dynamics change, should they change.

當然，對於您問題的第二部分，我們非常密切地追蹤經濟狀況和整體盈利能力。我們腦子裡有具體的場景，什麼時候我們認為這些是有吸引力的，什麼時候它們開始變得更加邊緣化，並且我們已經制定了計劃，根據這些動態的變化（如果它們發生變化）做出反應。

But as it stands right now, our focus is to extend our branded life cycle as long as we can. Our organization, our US team, from my perspective, has delivered a highly atypical performance for over three years since LOA, which provides incredibly important profits for the business, particularly for our growth in Europe.

但就目前而言，我們的重點是盡可能延長我們的品牌生命週期。從我的角度來看，我們的組織、我們的美國團隊自LOA 以來的三年多時間裡取得了非常非典型的業績，這為我們的業務，特別是我們在歐洲的成長提供了極其重要的利潤。

So we couldn't be happier in terms of how we finished the year and how we started the year. But as you well know, it's highly dynamic. We monitor it very closely.

因此，我們對這一年的結束和開始感到非常高興。但正如您所知，它是高度動態的。我們非常密切地監控它。

Got it. Thank you so much.

知道了。太感謝了。

We have reached the end of the question-and-answer session. And I will now turn the call over to Patrick for closing remarks.

我們的問答環節已經結束。現在我將把電話轉給派崔克，讓他發表結束語。

Well, thank you all for your attention, and thanks for all the Q&A. We really appreciate the interest, and we look forward to having additional conversations on these important results in the coming days ahead. So thank you again for your time, and wish you a great day ahead. Thank you.

好的，感謝大家的關注，也感謝所有的問答。我們非常感謝您的關注，並期待在未來幾天就這些重要結果進行更多對話。再次感謝您抽出寶貴的時間，祝您有美好的一天。謝謝。

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束，此時您可以掛斷電話了。感謝您的參與。